Cleared Traditional

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) (K190154) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190154 · Biomerieux S.A. · Microbiology device
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May 2019
Decision
91d
Days
Class 2
Risk

K190154 is an FDA 510(k) clearance for the ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL). Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Biomerieux S.A. (Marcy-L'Etoile, FR). The FDA issued a Cleared decision on May 1, 2019 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomerieux S.A. devices

Submission Details

510(k) Number K190154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2019
Decision Date May 01, 2019
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 124
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K190154.
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
K191809 · Liofilchem S. R. L. · Aug 2019
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
K191953 · Biomerieux S.A. · Aug 2019
MTS Doxycycline 0.016 - 256 µg/mL
K190914 · Liofilchem S. R. L. · May 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
K190109 · Beckman Coulter, Inc. · Apr 2019
MTS Gentamicin 0.016 - 256 µg/mL
K190252 · Liofilchem S. R. L. · Mar 2019
MTS Ciprofloxacin 0.002 - 32 µg/mL
K183527 · Liofilchem S. R. L. · Mar 2019